CHMP拒绝罗氏阿瓦斯汀用于恶性胶质瘤

CHMP拒绝罗氏阿瓦斯汀用于恶性胶质瘤

                               
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发布日期：2014-05-28  来源：pmlive

欧洲药品监管机构近日表示，罗氏旗下最畅销药癌症药物阿瓦斯汀不应获批用于恶性胶质瘤。

欧洲药品管理局人用医药产品委员会(CHMP)对阿瓦斯汀（贝伐单抗）结合目前标准治疗方案放疗及替莫唑胺用于恶性胶质瘤发布一项否定意见，称罗氏提交的用来支持申请的临床试验数据不符合要求。尽管阿瓦斯汀已在美国和日本被批准用于治疗恶性胶质瘤。

罗氏最大规模的研究招募有900多名患者，研究显示阿瓦斯汀能改善无进展生存期(PFS)，但CHMP认定这一结果“不可能被认为有临床相关性，因为用来检测脑瘤体积的方法有局限。”

顾问小组认为这款药物对这种脑癌的收益未超过其风险，恶性胶质瘤占所有类型脑癌的15%，通常发生在45至70岁的成年人当中。

阿瓦斯汀自2005年上市，这款药物已被批准用于结肠癌、乳腺癌、肺癌、肾癌和卵巢癌等肿瘤。它是罗氏第二大最畅销药物，去年销售额达到62.5亿瑞士法郎（大约70亿美元）。

在最近的会议中，CHMP经过重新审查后还对AB科学的马赛替尼（Masitinib）用于晚期胰腺癌及诺华心衰药物Serelaxin发布否定意见。这两款药物最初在今年初就曾被拒绝过。

CHMP还报道说，Servier已选择撤回骨质疏松症治疗药物雷尼酸锶增加适应症（包括膝盖和臀部骨关节炎）的申请。该公司一项由1600名患者参与的研究以失败告终，CHMP指出在该药物用于骨关节炎没有进一步的证据，因而无法获得批准，随后该公司撤回其申请。

CHMP turns down Avastin for brain cancerRoche set to be denied expanded use for oncology drug in Europe

Roche's big-selling cancer drug Avastin should not be approved for use in glioblastoma - a form of brain cancer - according to the EU regulator.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the use of Avastin (bevacizumab) alongside radiation therapy and temozolomide inglioblastoma - the current standard of care - saying the clinical data submitted by Roche to support its application did not pass muster.

The CHMP's latest round of opinions included recommendations for six new medicines. The negative decision for Avastin comes despite the fact that the drug has already been approved in both the US and Japan to treat glioblastoma.

Roche's largest study - which enrolled more than 900 patients - showed that Avastin was able to improve progression-free survival (PFS) when added to the background treatment, but the CHMP concluded that this finding "could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours."

The panel was also unhappy that there was no improvement in overall survival (OS), concluding that on balance the benefits of the drug did not outweigh its risks in this form of brain cancer, which constitutes 15 per cent of all nervous system tumours and commonly occurs in adults aged 45 to 70 years.

Avastin has been on the market since 2005 and is already approved to treat several malignancies, including colorectal, breast, lung, kidney and ovarian cancers. It is Roche's second biggest-selling drug, bringing in sales of 6.25bn Swiss francs (around $7bn) last year.

At its meeting last week the CHMP also confirmed its negative opinion - after a re-examination - on AB Science's Masiviera (masitinib) for certain types of advanced pancreatic cancer and Novartis' heart failure drug Reasanz(serelaxin). Both drugs were originally rejected earlier this year.

It also reported that Servier had elected to withdraw its application to extend the indications of its osteoporosis therapy Protelos/Osser (strontium ranelate) to include osteoarthritis of the knee and hip.

The company had filed a 1,600-patient study in support of the application but withdrew it after the CHMP indicated the dossier was likely not approvable without further evidence of the drug's benefits in osteoarthritis.

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